Matzim LA

In shortageOrange BookUNIISPLATC C05AE03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5254469519
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-19)
ndc11
5254469530
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-30)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A077686

ABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Diltiazem Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "OLH94387TE",
    "rxcui": "203211",
    "inchikey": "HDRXZJPWHTXQRI-BHDTVMLSSA-N",
    "display_name": "DILTIAZEM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e8c8dd18-9d95-4068-9762-bec1eb1bc25c": {
      "match": "brand_token",
      "title": "MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-08"
    }
  },
  "productid": "52544-695_6b586f35-6eb1-488c-839e-581f695d3f07",
  "productndc": "52544-695",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077686",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "420MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "360MG",
        "product_no": "002",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "004",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "006",
        "approval_date": "Mar 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DILTIAZEM HYDROCHLORIDE",
  "shortage_reason": "Diltiazem Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Matzim LA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077686",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20110328",
  "active_numerator_strength": "420"
}

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